Invivyd Developing Vaccine-Alternative Antibody to Prevent COVID

The FDA has cleared Invivyd’s Investigational New Drug (IND) application and provided feedback to advance the Connecticut-based company’s development program for VYD2311, a vaccine-alternative monoclonal antibody candidate for the prevention of COVID.

As part of the company’s Revolution clinical program, Invivyd’s Declaration Phase 3 clinical trial will evaluate VYD2311 safety and prevention of COVID versus placebo. The Liberty clinical trial will assess the safety and tolerability of VYD2311 in a head-to-head clinical trial against mRNA-based COVID vaccine, as well as evaluate co-administration of VYD2311 with vaccination, subject to final alignment with the FDA.

Invivyd intends to initiate these clinical trials as soon as practicable, with the goal of year-end 2025 trial start and top-line data mid-2026. Together, these clinical trials are designed to provide robust, medical practice-changing information to regulators, populations at risk for COVID, and policy makers seeking high-quality, safe, non-vaccine protection from COVID.

Invivyd expects that its clinical program may also include pediatric and other post-approval Phase 4 studies designed to establish VYD2311 and potential future Invivyd antibodies as the preferred option for protection from COVID over mRNA-based vaccination going forward.

“We are moving as fast as possible to bring Americans a new choice in protection from COVID,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “We have designed the clinical trials towards providing Americans with a convenient, safe, high-quality protective option to avoid COVID harm and burden without repeated use of inflammatory COVID vaccines.”

VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. (Source: Invivyd Website, 06 October, 2025)